NO334298B1 - Tablettpreparat med forlenget frigjøring av pramipexol - Google Patents

Tablettpreparat med forlenget frigjøring av pramipexol Download PDF

Info

Publication number: NO334298B1
Authority: NO; Norway
Prior art keywords: tablet; tensile strength; weight; preparation according; starch
Prior art date: 2002-07-25

Application number

NO20050093A

Other languages

English (en)

Norwegian (no)

Other versions

NO20050093L (no

Inventor

Joseph P Reo

Robert M Noack

Gregory E Amidon

Loksidh D Ganorkar

John M Heimlich

Ernest Lee

Connie J Skoug

Original Assignee

Boehringer Ingelheim Int

Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)

2002-07-25

Filing date

2005-01-06

Publication date

2014-01-27

2005-01-06 Application filed by Boehringer Ingelheim Int filed Critical Boehringer Ingelheim Int

2005-02-24 Publication of NO20050093L publication Critical patent/NO20050093L/no

2014-01-27 Publication of NO334298B1 publication Critical patent/NO334298B1/no

Links

FASDKYOPVNHBLU-ZETCQYMHSA-N pramipexole Chemical compound C1[C@@H](NCCC)CCC2=C1SC(N)=N2 FASDKYOPVNHBLU-ZETCQYMHSA-N 0.000 title claims abstract description 43
229960003089 pramipexole Drugs 0.000 title claims abstract description 36
238000002360 preparation method Methods 0.000 title claims description 38
230000002035 prolonged effect Effects 0.000 title description 13
229920002472 Starch Polymers 0.000 claims abstract description 45
235000019698 starch Nutrition 0.000 claims abstract description 45
239000008107 starch Substances 0.000 claims abstract description 43
239000007787 solid Substances 0.000 claims abstract description 30
229920001477 hydrophilic polymer Polymers 0.000 claims abstract description 17
150000003839 salts Chemical class 0.000 claims abstract description 17
239000011159 matrix material Substances 0.000 claims abstract description 13
239000003826 tablet Substances 0.000 claims description 135
239000011248 coating agent Substances 0.000 claims description 45
238000000576 coating method Methods 0.000 claims description 45
229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 34
235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 34
239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 32
UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims description 31
229920000881 Modified starch Polymers 0.000 claims description 27
229960002652 pramipexole dihydrochloride Drugs 0.000 claims description 17
VQMNWIMYFHHFMC-UHFFFAOYSA-N tert-butyl 4-hydroxyindole-1-carboxylate Chemical group C1=CC=C2N(C(=O)OC(C)(C)C)C=CC2=C1O VQMNWIMYFHHFMC-UHFFFAOYSA-N 0.000 claims description 17
238000012360 testing method Methods 0.000 claims description 16
ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 claims description 15
238000011282 treatment Methods 0.000 claims description 15
239000001856 Ethyl cellulose Substances 0.000 claims description 10
229920001249 ethyl cellulose Polymers 0.000 claims description 10
235000019325 ethyl cellulose Nutrition 0.000 claims description 10
229950010601 pramipexole dihydrochloride monohydrate Drugs 0.000 claims description 9
208000018737 Parkinson disease Diseases 0.000 claims description 7
239000000825 pharmaceutical preparation Substances 0.000 claims description 6
239000007891 compressed tablet Substances 0.000 claims description 4
238000013265 extended release Methods 0.000 claims description 4
230000002209 hydrophobic effect Effects 0.000 claims description 4
NIXOWILDQLNWCW-UHFFFAOYSA-N Acrylic acid Chemical compound OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims description 3
229920002125 Sokalan® Polymers 0.000 claims description 3
229920000609 methyl cellulose Polymers 0.000 claims description 3
239000001923 methylcellulose Substances 0.000 claims description 3
235000010981 methylcellulose Nutrition 0.000 claims description 3
DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 2
229960001631 carbomer Drugs 0.000 claims description 2
LNAZSHAWQACDHT-XIYTZBAFSA-N (2r,3r,4s,5r,6s)-4,5-dimethoxy-2-(methoxymethyl)-3-[(2s,3r,4s,5r,6r)-3,4,5-trimethoxy-6-(methoxymethyl)oxan-2-yl]oxy-6-[(2r,3r,4s,5r,6r)-4,5,6-trimethoxy-2-(methoxymethyl)oxan-3-yl]oxyoxane Chemical compound CO[C@@H]1[C@@H](OC)[C@H](OC)[C@@H](COC)O[C@H]1O[C@H]1[C@H](OC)[C@@H](OC)[C@H](O[C@H]2[C@@H]([C@@H](OC)[C@H](OC)O[C@@H]2COC)OC)O[C@@H]1COC LNAZSHAWQACDHT-XIYTZBAFSA-N 0.000 claims 1
238000013268 sustained release Methods 0.000 abstract description 15
239000012730 sustained-release form Substances 0.000 abstract description 15
239000008194 pharmaceutical composition Substances 0.000 abstract 1
239000000203 mixture Substances 0.000 description 27
238000004090 dissolution Methods 0.000 description 18
230000006835 compression Effects 0.000 description 16
238000007906 compression Methods 0.000 description 16
239000003814 drug Substances 0.000 description 15
XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 14
239000000463 material Substances 0.000 description 13
239000003795 chemical substances by application Substances 0.000 description 12
229940079593 drug Drugs 0.000 description 12
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238000000338 in vitro Methods 0.000 description 11
239000002552 dosage form Substances 0.000 description 10
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238000002648 combination therapy Methods 0.000 description 9
238000001727 in vivo Methods 0.000 description 9
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238000010998 test method Methods 0.000 description 9
HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 8
238000010521 absorption reaction Methods 0.000 description 7
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239000012530 fluid Substances 0.000 description 3
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238000009097 single-agent therapy Methods 0.000 description 3
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230000004584 weight gain Effects 0.000 description 3
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VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 2
238000005299 abrasion Methods 0.000 description 2
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239000012736 aqueous medium Substances 0.000 description 2
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230000002496 gastric effect Effects 0.000 description 2
210000001035 gastrointestinal tract Anatomy 0.000 description 2
239000008172 hydrogenated vegetable oil Substances 0.000 description 2
229920001600 hydrophobic polymer Polymers 0.000 description 2
VZCYOOQTPOCHFL-UPHRSURJSA-N maleic acid Chemical compound OC(=O)\C=C/C(O)=O VZCYOOQTPOCHFL-UPHRSURJSA-N 0.000 description 2
229940101972 mirapex Drugs 0.000 description 2
230000036470 plasma concentration Effects 0.000 description 2
239000004014 plasticizer Substances 0.000 description 2
229920001223 polyethylene glycol Polymers 0.000 description 2
-1 polymorphs Chemical class 0.000 description 2
238000001812 pycnometry Methods 0.000 description 2
238000011002 quantification Methods 0.000 description 2
238000000611 regression analysis Methods 0.000 description 2
238000005070 sampling Methods 0.000 description 2
230000009747 swallowing Effects 0.000 description 2
239000000454 talc Substances 0.000 description 2
235000012222 talc Nutrition 0.000 description 2
229910052623 talc Inorganic materials 0.000 description 2
VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 description 2
229920003176 water-insoluble polymer Polymers 0.000 description 2
SMZOUWXMTYCWNB-UHFFFAOYSA-N 2-(2-methoxy-5-methylphenyl)ethanamine Chemical compound COC1=CC=C(C)C=C1CCN SMZOUWXMTYCWNB-UHFFFAOYSA-N 0.000 description 1
HBAQYPYDRFILMT-UHFFFAOYSA-N 8-[3-(1-cyclopropylpyrazol-4-yl)-1H-pyrazolo[4,3-d]pyrimidin-5-yl]-3-methyl-3,8-diazabicyclo[3.2.1]octan-2-one Chemical class C1(CC1)N1N=CC(=C1)C1=NNC2=C1N=C(N=C2)N1C2C(N(CC1CC2)C)=O HBAQYPYDRFILMT-UHFFFAOYSA-N 0.000 description 1
206010067484 Adverse reaction Diseases 0.000 description 1
229920000945 Amylopectin Polymers 0.000 description 1
229920002134 Carboxymethyl cellulose Polymers 0.000 description 1
229940096895 Dopamine D2 receptor agonist Drugs 0.000 description 1
UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 description 1
229920000663 Hydroxyethyl cellulose Polymers 0.000 description 1
239000004354 Hydroxyethyl cellulose Substances 0.000 description 1
229920002153 Hydroxypropyl cellulose Polymers 0.000 description 1
241000124008 Mammalia Species 0.000 description 1
240000003183 Manihot esculenta Species 0.000 description 1
235000016735 Manihot esculenta subsp esculenta Nutrition 0.000 description 1
241001465754 Metazoa Species 0.000 description 1
CERQOIWHTDAKMF-UHFFFAOYSA-N Methacrylic acid Chemical compound CC(=C)C(O)=O CERQOIWHTDAKMF-UHFFFAOYSA-N 0.000 description 1
229920003091 Methocel™ Polymers 0.000 description 1
239000004368 Modified starch Substances 0.000 description 1
FASDKYOPVNHBLU-UHFFFAOYSA-N N6-Propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine Chemical compound C1C(NCCC)CCC2=C1SC(N)=N2 FASDKYOPVNHBLU-UHFFFAOYSA-N 0.000 description 1
240000007594 Oryza sativa Species 0.000 description 1
235000007164 Oryza sativa Nutrition 0.000 description 1
RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 description 1
229920003171 Poly (ethylene oxide) Polymers 0.000 description 1
239000004372 Polyvinyl alcohol Substances 0.000 description 1
DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 description 1
244000061456 Solanum tuberosum Species 0.000 description 1
235000002595 Solanum tuberosum Nutrition 0.000 description 1
235000021355 Stearic acid Nutrition 0.000 description 1
241000209140 Triticum Species 0.000 description 1
235000021307 Triticum Nutrition 0.000 description 1
240000008042 Zea mays Species 0.000 description 1
235000005824 Zea mays ssp. parviglumis Nutrition 0.000 description 1
235000002017 Zea mays subsp mays Nutrition 0.000 description 1
VJHCJDRQFCCTHL-UHFFFAOYSA-N acetic acid 2,3,4,5,6-pentahydroxyhexanal Chemical compound CC(O)=O.OCC(O)C(O)C(O)C(O)C=O VJHCJDRQFCCTHL-UHFFFAOYSA-N 0.000 description 1
239000013543 active substance Substances 0.000 description 1
230000006838 adverse reaction Effects 0.000 description 1
238000003556 assay Methods 0.000 description 1
239000002585 base Substances 0.000 description 1
239000008280 blood Substances 0.000 description 1
210000004369 blood Anatomy 0.000 description 1
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CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 description 1
235000013539 calcium stearate Nutrition 0.000 description 1
239000008116 calcium stearate Substances 0.000 description 1
235000019519 canola oil Nutrition 0.000 description 1
239000000828 canola oil Substances 0.000 description 1
125000003178 carboxy group Chemical group [H]OC(*)=O 0.000 description 1
235000010948 carboxy methyl cellulose Nutrition 0.000 description 1
229940063834 carboxymethylcellulose sodium Drugs 0.000 description 1
229950008138 carmellose Drugs 0.000 description 1
239000000679 carrageenan Substances 0.000 description 1
235000010418 carrageenan Nutrition 0.000 description 1
229920001525 carrageenan Polymers 0.000 description 1
229940113118 carrageenan Drugs 0.000 description 1
229920002678 cellulose Polymers 0.000 description 1
239000001913 cellulose Substances 0.000 description 1
229920002301 cellulose acetate Polymers 0.000 description 1
239000011436 cob Substances 0.000 description 1
238000004590 computer program Methods 0.000 description 1
230000003750 conditioning effect Effects 0.000 description 1
239000000470 constituent Substances 0.000 description 1
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235000005822 corn Nutrition 0.000 description 1
230000001186 cumulative effect Effects 0.000 description 1
230000001627 detrimental effect Effects 0.000 description 1
FSBVERYRVPGNGG-UHFFFAOYSA-N dimagnesium dioxido-bis[[oxido(oxo)silyl]oxy]silane hydrate Chemical compound O.[Mg+2].[Mg+2].[O-][Si](=O)O[Si]([O-])([O-])O[Si]([O-])=O FSBVERYRVPGNGG-UHFFFAOYSA-N 0.000 description 1
239000012738 dissolution medium Substances 0.000 description 1
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239000002288 dopamine 2 receptor stimulating agent Substances 0.000 description 1
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150000002148 esters Chemical class 0.000 description 1
MVPICKVDHDWCJQ-UHFFFAOYSA-N ethyl 3-pyrrolidin-1-ylpropanoate Chemical compound CCOC(=O)CCN1CCCC1 MVPICKVDHDWCJQ-UHFFFAOYSA-N 0.000 description 1
230000002349 favourable effect Effects 0.000 description 1
230000009969 flowable effect Effects 0.000 description 1
239000012458 free base Substances 0.000 description 1
FETSQPAGYOVAQU-UHFFFAOYSA-N glyceryl palmitostearate Chemical compound OCC(O)CO.CCCCCCCCCCCCCCCC(O)=O.CCCCCCCCCCCCCCCCCC(O)=O FETSQPAGYOVAQU-UHFFFAOYSA-N 0.000 description 1
229940046813 glyceryl palmitostearate Drugs 0.000 description 1
239000001307 helium Substances 0.000 description 1
229910052734 helium Inorganic materials 0.000 description 1
SWQJXJOGLNCZEY-UHFFFAOYSA-N helium atom Chemical compound [He] SWQJXJOGLNCZEY-UHFFFAOYSA-N 0.000 description 1
238000000589 high-performance liquid chromatography-mass spectrometry Methods 0.000 description 1
150000004677 hydrates Chemical class 0.000 description 1
125000004356 hydroxy functional group Chemical group O* 0.000 description 1
235000019447 hydroxyethyl cellulose Nutrition 0.000 description 1
239000001863 hydroxypropyl cellulose Substances 0.000 description 1
235000010977 hydroxypropyl cellulose Nutrition 0.000 description 1
229960003943 hypromellose Drugs 0.000 description 1
239000012728 immediate-release (IR) tablet Substances 0.000 description 1
230000001771 impaired effect Effects 0.000 description 1
239000004615 ingredient Substances 0.000 description 1
230000000977 initiatory effect Effects 0.000 description 1
230000003993 interaction Effects 0.000 description 1
238000001990 intravenous administration Methods 0.000 description 1
239000000395 magnesium oxide Substances 0.000 description 1
CPLXHLVBOLITMK-UHFFFAOYSA-N magnesium oxide Inorganic materials [Mg]=O CPLXHLVBOLITMK-UHFFFAOYSA-N 0.000 description 1
235000012245 magnesium oxide Nutrition 0.000 description 1
239000000391 magnesium silicate Substances 0.000 description 1
235000019793 magnesium trisilicate Nutrition 0.000 description 1
229940099273 magnesium trisilicate Drugs 0.000 description 1
229910000386 magnesium trisilicate Inorganic materials 0.000 description 1
AXZKOIWUVFPNLO-UHFFFAOYSA-N magnesium;oxygen(2-) Chemical compound [O-2].[Mg+2] AXZKOIWUVFPNLO-UHFFFAOYSA-N 0.000 description 1
238000005259 measurement Methods 0.000 description 1
238000002844 melting Methods 0.000 description 1
230000008018 melting Effects 0.000 description 1
206010027175 memory impairment Diseases 0.000 description 1
125000000956 methoxy group Chemical group [H]C([H])([H])O* 0.000 description 1
235000010446 mineral oil Nutrition 0.000 description 1
239000002480 mineral oil Substances 0.000 description 1
235000019426 modified starch Nutrition 0.000 description 1
150000004682 monohydrates Chemical class 0.000 description 1
231100001079 no serious adverse effect Toxicity 0.000 description 1
QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 1
OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 description 1
230000003204 osmotic effect Effects 0.000 description 1
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239000006187 pill Substances 0.000 description 1
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229920002451 polyvinyl alcohol Polymers 0.000 description 1
235000019422 polyvinyl alcohol Nutrition 0.000 description 1
229920000036 polyvinylpyrrolidone Polymers 0.000 description 1
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235000009566 rice Nutrition 0.000 description 1
WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 description 1
235000010234 sodium benzoate Nutrition 0.000 description 1
239000004299 sodium benzoate Substances 0.000 description 1
235000019333 sodium laurylsulphate Nutrition 0.000 description 1
229940045902 sodium stearyl fumarate Drugs 0.000 description 1
239000012453 solvate Substances 0.000 description 1
241000894007 species Species 0.000 description 1
239000008117 stearic acid Substances 0.000 description 1
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QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 description 1
235000019731 tricalcium phosphate Nutrition 0.000 description 1
XOOUIPVCVHRTMJ-UHFFFAOYSA-L zinc stearate Chemical compound [Zn+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O XOOUIPVCVHRTMJ-UHFFFAOYSA-L 0.000 description 1
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Classifications

- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/425—Thiazoles
- A61K31/428—Thiazoles condensed with carbocyclic rings
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
- A61K31/4738—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems
- A61K31/4745—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
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- A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
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- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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NO20050093A 2002-07-25 2005-01-06 Tablettpreparat med forlenget frigjøring av pramipexol NO334298B1 (no)

Applications Claiming Priority (4)

Application Number	Priority Date	Filing Date	Title
US39842702P	2002-07-25	2002-07-25
US39844702P	2002-07-25	2002-07-25
US47951303P	2003-06-18	2003-06-18
PCT/US2003/023205 WO2004010997A1 (en)	2002-07-25	2003-07-25	Sustained-release tablet composition of pramipexole

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EP (2)	EP1531814B1 (es)
JP (1)	JP4700963B2 (es)
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CN (1)	CN1313092C (es)
AP (1)	AP2201A (es)
AR (1)	AR040681A1 (es)
AT (1)	ATE406162T1 (es)
AU (1)	AU2003261241B2 (es)
BR (1)	BR0312960A (es)
CA (1)	CA2492854C (es)
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CU (1)	CU23440B7 (es)
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DE (1)	DE60323235D1 (es)
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EC (1)	ECSP055568A (es)
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GE (1)	GEP20074048B (es)
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NO (1)	NO334298B1 (es)
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PT (1)	PT1531814E (es)
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UY (1)	UY27912A1 (es)
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- 2003-07-25 RS YU20050059A patent/RS51719B/sr unknown
- 2003-07-25 EA EA200702187A patent/EA200702187A1/ru unknown
- 2003-07-25 KR KR1020057001392A patent/KR100712832B1/ko not_active IP Right Cessation
- 2003-07-25 DK DK03771807T patent/DK1531814T3/da active
- 2003-07-25 MX MXPA05001054A patent/MXPA05001054A/es active IP Right Grant
- 2003-07-25 BR BR0312960-8A patent/BR0312960A/pt not_active IP Right Cessation
- 2003-07-25 PT PT03771807T patent/PT1531814E/pt unknown
- 2003-07-25 TW TW092120406A patent/TWI347849B/zh not_active IP Right Cessation
- 2003-07-25 ME MEP-523/08A patent/MEP52308A/xx unknown
- 2003-07-25 CA CA002492854A patent/CA2492854C/en not_active Expired - Fee Related
- 2003-07-25 AT AT03771807T patent/ATE406162T1/de active
- 2003-07-25 CN CNB038178737A patent/CN1313092C/zh not_active Expired - Fee Related
- 2003-07-25 OA OA1200500016A patent/OA13303A/en unknown
- 2003-07-25 DE DE60323235T patent/DE60323235D1/de not_active Expired - Lifetime
- 2003-07-25 AP AP2005003205A patent/AP2201A/xx active
- 2003-07-25 GE GEAP8599A patent/GEP20074048B/en unknown
- 2003-07-25 SI SI200331350T patent/SI1531814T1/sl unknown
- 2003-07-25 ES ES03771807T patent/ES2310673T3/es not_active Expired - Lifetime
- 2003-07-25 EA EA200500079A patent/EA009663B1/ru not_active IP Right Cessation
- 2003-07-25 EP EP03771807A patent/EP1531814B1/en not_active Expired - Lifetime
- 2003-07-25 PL PL375696A patent/PL215587B1/pl unknown
- 2003-07-25 NZ NZ537790A patent/NZ537790A/en unknown
- 2003-07-25 EP EP08159203A patent/EP1987832A1/en not_active Withdrawn
- 2003-07-25 AU AU2003261241A patent/AU2003261241B2/en not_active Ceased
- 2003-07-25 JP JP2004524787A patent/JP4700963B2/ja not_active Expired - Fee Related
- 2003-07-25 WO PCT/US2003/023205 patent/WO2004010997A1/en active IP Right Grant
- 2003-07-31 UY UY27912A patent/UY27912A1/es not_active Application Discontinuation
2004
- 2004-12-29 IS IS7623A patent/IS7623A/is unknown
- 2004-12-30 IL IL16607804A patent/IL166078A0/xx unknown
- 2004-12-30 HR HRP20041235AA patent/HRP20041235B1/hr not_active IP Right Cessation
2005
- 2005-01-06 NO NO20050093A patent/NO334298B1/no not_active IP Right Cessation
- 2005-01-17 ZA ZA200500439A patent/ZA200500439B/xx unknown
- 2005-01-24 CR CR7661A patent/CR7661A/es unknown
- 2005-01-24 EC EC2005005568A patent/ECSP055568A/es unknown
- 2005-01-25 MA MA28066A patent/MA27328A1/fr unknown
- 2005-01-25 CU CU20050018A patent/CU23440B7/es not_active IP Right Cessation
- 2005-11-08 HK HK05109947A patent/HK10777456A1/xx unknown
2008
- 2008-10-13 CY CY20081101125T patent/CY1110408T1/el unknown
2010
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Also Published As

Publication number	Publication date
HRP20041235A2 (en)	2005-06-30
MXPA05001054A (es)	2005-04-08
ECSP055568A (es)	2005-04-18
GEP20074048B (en)	2007-02-26
IL166078A0 (en)	2006-01-15
PA8578301A1 (es)	2004-07-20
DK1531814T3 (da)	2008-10-13
CA2492854A1 (en)	2004-02-05
AP2201A (en)	2011-01-24
JP4700963B2 (ja)	2011-06-15
EP1531814B1 (en)	2008-08-27
CR7661A (es)	2005-06-08
KR100712832B1 (ko)	2007-04-30
RS20050059A (en)	2007-08-03
WO2004010997A8 (en)	2005-02-24
CN1671382A (zh)	2005-09-21
PL375696A1 (en)	2005-12-12
KR20050062516A (ko)	2005-06-23
US20050226926A1 (en)	2005-10-13
OA13303A (en)	2007-04-13
NO20050093L (no)	2005-02-24
EA009663B1 (ru)	2008-02-28
ZA200500439B (en)	2006-08-30
PT1531814E (pt)	2008-10-29
WO2004010997A1 (en)	2004-02-05
JP2005538106A (ja)	2005-12-15
SI1531814T1 (sl)	2008-12-31
CA2492854C (en)	2009-10-20
HRP20041235B1 (hr)	2013-07-31
US20100316710A1 (en)	2010-12-16
MEP52308A (en)	2011-02-10
AU2003261241B2 (en)	2009-06-18
RS51719B (sr)	2011-10-31
ES2310673T3 (es)	2009-01-16
HK10777456A1 (en)	2007-11-30
PL215587B1 (pl)	2013-12-31
IS7623A (is)	2004-12-29
TW200418523A (en)	2004-10-01
AU2003261241A1 (en)	2004-02-16
DE60323235D1 (de)	2008-10-09
TWI347849B (en)	2011-09-01
EP1531814A1 (en)	2005-05-25
EP1987832A1 (en)	2008-11-05
EA200500079A1 (ru)	2005-06-30
US8399016B2 (en)	2013-03-19
MY138846A (en)	2009-07-31
CN1313092C (zh)	2007-05-02
AP2005003205A0 (en)	2005-03-31
MA27328A1 (fr)	2005-05-02
PE20040130A1 (es)	2004-03-06
NZ537790A (en)	2005-10-28
AR040681A1 (es)	2005-04-13
UY27912A1 (es)	2004-02-27
CY1110408T1 (el)	2015-04-29
EA200702187A1 (ru)	2008-06-30
BR0312960A (pt)	2005-06-14
CU23440B7 (es)	2009-10-16
ATE406162T1 (de)	2008-09-15

Publication	Publication Date	Title
NO334298B1 (no)	2014-01-27	Tablettpreparat med forlenget frigjøring av pramipexol
JP4607584B2 (ja)	2011-01-05	プラミペキソールの１日１回投与剤形
IL166079A (en)	2012-08-30	Sustained-release tablet comprising reboxetine

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